Study of Arry-520 and Carfilzomib in Patients With Relapsed/Refractory Multiple Myeloma

This study is ongoing, but not recruiting participants.

Sponsor:

M.D. Anderson Cancer Center

ClinicalTrials.gov Identifier:

NCT01372540

First Posted: June 14, 2011

Last Update Posted: December 28, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

This study is divided into study groups, as described below. The goal of Groups 1A and 2A of this clinical research study is to find the highest tolerable dose of the combination of ARRY-520 and carfilzomib that can be given to patients with multiple myeloma or plasma cell leukemia.

The goal of Groups 1B and 2B of this study is to learn if the combination of carfilzomib and ARRY-520 can help to control multiple myeloma or plasma cell leukemia. Researchers would also like to learn if ARRY-520 can help carfilzomib to work in patients who have built up a resistance to carfilzomib or carfilzomib alone has not helped to control the disease.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Confirmed relapsed or refractory MM or PCL. Patients should have received at least 1 prior treatment regimen. Prior treatment must have included at least one full cycle of a proteasome inhibitor (e.g., bortezomib) and at least one full cycle of an IMiD (e.g., thalidomide, lenalidomide or pomalidomide). Patients who have had prior ARRY-520 and carfilzomib will be allowed in the dose escalation phase, however prior ARRY-520 and carfilzomib will be excluded in the dose expansion cohort 1 of Part A. There will be 2 cohorts in the dose expansion of part A: Cohort 1 will be patients who are carfilzomib sensitive; Cohort 2 will be patients who are carfilzomib refractory.

Continuation of Inclusion Criteria #1: Part B: For Part B dose expansion: Once a MTD has been established in Part A, additional dose escalation will occur with subsequent dose escalation of Carfilzomib. During the dose escalation of Part B, pt must have at least 1 line of prior therapy and no limitations on prior therapy. Patients who had prior clinical benefit/response to ARRY-520 or Carfilzomib with a SD or better may be eligible for dose expansion of Part B. Dose expansion of part B will be patients who are carfilzomib sensitive.

Female patients who: Are postmenopausal for at least 1 year before the screening visit, OR Are surgically sterile, OR If they are of childbearing potential, ( those who are post menopausal for less than 1 year) must have negative serum or urine pregnancy test and agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 30 days after the last dose of study drug, or agree to completely abstain from heterosexual intercourse. Male patients, even if surgically sterilized (i.e., status postvasectomy), who: Agree to practice effective barrier contraception during the entire study treatment period and through 30 days after the last dose of study drug, OR Agree to completely abstain from heterosexual intercourse.

Understand and voluntarily signed informed consent.

Exclusion Criteria:

Primary amyloidosis.

Treatment with an investigational product or device within 21 days of Cycle 1 Day 1.

History of allergic reaction/hypersensitivity to any of the study medications, their analogues or excipients in the various formulations.

Cytotoxic therapy or monoclonal antibodies within 21 days prior to Cycle 1 Day 1.

Radiotherapy within 21 days prior to Cycle 1 Day 1. However, if the radiation portal covered </= 5% of the bone marrow reserve, the patient may be enrolled irrespective of the end date of radiotherapy.

Major surgery within 14 days and minor surgery within 7 days prior to Cycle 1 Day 1.

Corticosteroid doses > 10 mg/day of prednisone or equivalent within 14 days prior to Cycle 1 Day 1.

Medical, psychiatric, cognitive or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol or to complete the study or, in the judgment of the Investigator, would make the patient inappropriate for study participation.

Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize carfilzomib)

Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment